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ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder.

ABSTRACT: INTRODUCTION:Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition with impacts on behaviour, cognition, communication, social interaction and family mental health. This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD. METHODS AND ANALYSIS:We aim to recruit 66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT. Families will be randomly assigned to care-as-usual or ENACT. ENACT is a very early intervention, leveraging parent-child interactions to improve early social reciprocity, while supporting parental mental health and the parent-child relationship through Acceptance and Commitment Therapy. Intervention content is delivered online (approximately 8 hours) and supported by more than 7 consultations with a clinician. Parents will perform the social reciprocity intervention with their child (30 min per day). Assessments at four time points (baseline, 3 months, 6 months, and 12 months corrected age) will assess parent-infant interaction, parental mental health, infant development and early ASD markers. Analysis will be by intention to treat using general linear models for RCTs. ETHICS AND DISSEMINATION:This protocol has been approved by the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/50131) and the University of Queensland Human Research Ethics Committee (2019000558). If efficacy is demonstrated, the intervention has the potential for wide and accessible dissemination. TRIAL REGISTRATION NUMBER:Australian New Zealand Clinical Trials Registry (ACTRN12618002046280).

SUBMITTER: Whittingham K

PROVIDER: S-EPMC7440709 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder.

Whittingham Koa K McGlade Andrea A Kulasinghe Kavindri K Mitchell Amy E AE Heussler Honey H Boyd Roslyn N RN

BMJ open 20200820 8

<h4>Introduction</h4>Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition with impacts on behaviour, cognition, communication, social interaction and family mental health. This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.<h4>Methods and analysis</h4>We aim to recruit 66 mothers of infan ...[more]

PMID: 32819928

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Project description:IntroductionNew international clinical practice guidelines exist for identifying infants at high risk of cerebral palsy (CP) earlier: between 12 to 24 weeks corrected age, significantly earlier than previous diagnosis windows in Australia at 19 months. The earlier detection of infants at high risk of CP creates an opportunity for earlier intervention. The quality of the parent-infant relationship impacts various child outcomes, and is leveraged in other forms of intervention. This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP. We predict that participating in the Early PACT programme will be associated with improvements in the parent-infant relationship, in parent mental health and well-being as well as infant behaviour and quality of life.Methods and analysisThis study aims to recruit 60 parents of infants (0 to 2 years old corrected age) diagnosed with CP or identified as at high risk of having CP. Participants will be randomly allocated to one of two groups: Early PACT or waitlist control (1:1). Early PACT is an online parent support programme grounded in Acceptance and Commitment Therapy (ACT). It is delivered as a course on an open source course management system called edX. Early PACT is designed to support parental adjustment and parent-infant relationship around the time of early diagnosis. Assessments will be conducted at baseline, following completion of Early PACT and at 6-month follow-up (retention). The primary outcome will be the quality of parent-child interactions as measured by the Emotional Availability Scale. Standard analysis methods for randomised controlled trial will be used to make comparisons between the two groups (Early PACT and waitlist control). Retention of effects will be examined at 6-month follow-up.Ethics and disseminationThis study is approved through appropriate Australian and New Zealand ethics committees (see in text) with parents providing written informed consent. Findings from this trial will be disseminated through peer-reviewed journal publications and conference presentations.Trial registration detailsThis trial has been prospectively registered on 12 June 2018 to present (ongoing) with the Australian New Zealand Clinical Trials Registry (ACTRN12618000986279); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=3 74 896.

Dataset Information

ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder.

Publications

ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder.

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